MAUDE Adverse Event Report: NOVOCURE LTD. OPTUNE

Model Number	TFH-9000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Post Operative Wound Infection (2446)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Novocure agrees with the prescribing physician that the events were not related to optune therapy.Other contributing factors for wound infection, wound dehiscence and resulting brain abscess in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information), concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), advanced age (b)(6), warfarin use, underlying cancer disease, prior radiation and prior surgery affecting skin integrity.Brain abscess, wound infection and wound dehiscence were not reported as adverse events in the ef-11 recurrent gbm pivotal trial.There have been 4 reports of abscesses, 15 reports of wound infection, and 19 reports of wound dehiscence in the commercial program to date.
Event or Problem Description
Patient with recurrent glioblastoma began optune therapy on (b)(6) 2016.On (b)(6) 2016, patient's daughter reported patient was hospitalized due to an open wound with dehiscence at the site of the patient's previous surgical resection scar (resection on (b)(6) 2016).Per discharge summary, patient was admitted (b)(6) 2016 for wound dehiscence and suspected abscess of the brain.Patient underwent repeat craniotomy and drainage of brain abscess x2 on (b)(6) 2016, respectively.Deep wound cultures were positive for moraxella catarrhalis, beta lactamase, and propionibacterium acnes.Brain mri conducted on (b)(6) 2016 was stable when compared to previous mri conducted on (b)(6) 2016.Patient went on a 56 day course antibiotics (ceftriaxone) to treat infection and was discharged in good condition to a skilled nursing facility for short term rehabilitation on (b)(6) 2016.Per prescribing physician, the events were caused by skin breakdown and wound dehiscence due to concomitant bevacizumab usage.Physician stated the events were unlikely caused by optune therapy.

• Brand Name: OPTUNE
• Common Device Name: OPTUNE
• Manufacturer (Section D): NOVOCURE LTD.; topaz building, sha'ar; hacarmel 4th floor; haifa, is 31905 ; IS 31905
• MDR Report Key: 5621130
• Report Number: 3009453079-2016-00071
• Device Sequence Number: 18940541
• Product Code: NZK
• UDI-Device Identifier: 07290107980401
• UDI-Public: 07290107980401
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH-9000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2016
• Initial Report FDA Received Date: 04/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 82